Metacognitive Training in the Older Adults With Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HRSD-24)
研究概览
简要总结
Depression is one of the most common mental disorders in older adults and a major cause of years lived with disability. Depression does not always respond to antidepressants, and non-pharmacological interventions are recommended by international guidelines. The Metacognitive Training for Depression in Later Life (MCT-Silver) is a creative and innovative group intervention that aims to reduce depressive symptoms by challenging the cognitive and metacognitive beliefs characteristic of this disorder, that intends to enable participants to recognize and correct their automatic and dysfunctional thinking patterns and behavior. It was developed by the partner institution's team, and has already demonstrated positive results. This project aims to extend the research study to Portugal, through cultural adaptation, pilot study, and a Randomized Controlled Trial (RCT). To this end, we defined the following aims: To plan and conduct a pilot study to assess the efficacy of the MCT-Silver in the Portuguese population; To conduct a multicenter randomized controlled trial (RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent
- •Age: 60 years or older
- •Sufficient command of the Portuguese language
- •Willingness to participate in the intervention for a period of 4 to 8 weeks (participants who do not participate in the intervention will also be included in the analysis)
- •Adequate visual and hearing acuity for neuropsychological testing and participation in the group sessions
- •Values above 10 on the Hamilton Depression Scale
排除标准
- •Active psychotic symptoms (i.e., hallucinations, delusions, or manias)
- •Acute suicidal ideation
- •Cognitive impairment
- •Dementia or other neurological disease
结局指标
主要结局
Hamilton Depression Rating Scale (HRSD-24)
时间窗: Follow-up (6 months after the intervention)
The 24-item version of the Hamilton Depression Rating Scale is an established clinician-
次要结局
- Dysfunctional Attitudes Scale Form 18B (DAS-18B)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- Beck-Depressions-Inventar II (BDI-II)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- Mini Mental State Examination (MMSE)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- Attitudes to Ageing Questionnaire (AAQ)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- Ruminative Responses Scale(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- World Health Organization Quality of Life-BREF - Item 1(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- Patient Health Questionnaire 9 (PHQ-9)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- Metacognitions Questionnaire (MCQ-30)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- ICF Core Set for Depression(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
- Rosenberg Self-Esteem Scale(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
研究者
Lara Manuela Guedes de Pinho
Principal Investigator
University of Évora